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Taking people in United StatesNo phase

Imaging test to detect prostate cancer without a biopsy

Tests an MRI scan analysis method to detect prostate cancer in adults.

Key facts

Who runs it
Washington University School of Medicine
Where
St Louis, United StatesSee the site
Trial code
Registry title
Diffusion Basis Spectrum Imaging of the Prostate
Status
Recruiting
People taking part
500 people, planned
Started
27 Feb 2020
Expected to end
31 May 2027
Type of study
Interventional, 2 groups
Treatments tested
  • MRI with DBSI analysis
Record updated
9 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for men over 18 who are planning a prostate biopsy. They either have never been diagnosed with prostate cancer, or are on active surveillance for it.

Age
Over 18 years
Sex
Men only
Disease stage
Two groups: men with no prior prostate cancer diagnosis and an elevated PSA (with no prior biopsy or a negative prior biopsy), and men with prostate cancer managed with active surveillance.
Earlier treatment
Men who had prostate surgery for prostate cancer (for example radical prostatectomy or focal ablation) cannot join.
Biomarker or test result
An elevated PSA is asked for in the group with no prior prostate cancer diagnosis.

Main reasons for not taking part

  • Any medical reason that rules out an MRI scan
  • Metallic implants such as pacemakers or implantable cardioverter-defibrillators
  • Cochlear implants
  • Claustrophobia that medication does not relieve
  • Not able to lie flat for over 1 hour

The registry criteria, word for word

Show all 6 criteriaShow less

Who can take part

  • Over 18 years of age and willing and able to provide informed consent
  • Patients with no prior diagnosis of prostate cancer, who are planning to undergo prostate biopsy as clinical standard of care ("early detection cohort")
  • Including those men with:; an elevated PSA and no prior biopsy; an elevated PSA and a negative prior biopsy
  • Patients with a prior diagnosis of prostate cancer, who are currently managed with active surveillance, who are planning to undergo biopsy as clinical standard of care ("active surveillance cohort")

Who cannot take part

  • Patients with any clinical contraindication to MRI; *Including but not limited to:; Those with metallic implants, such as pacemakers or implantable cardioverter-defibrillators; Those with cochlear implants; Those with claustrophobia not relieved with medications (patients with claustrophobia who do not need medications for the scan or whose claustrophobia can be managed with medication, are eligible to participate); Those who cannot lie flat for over 1 hour
  • Patients with prior prostate surgery for prostate cancer (e.g. radical prostatectomy, focal ablation)

Where in United States

  • Washington University School of MedicineSt Louis, United StatesContact: Hongyu An, M.D., Ph.D.Taking people

About the trial

What the trial wants to find out

Diffusion Basis Spectrum Imaging (DBSI) represents a potential leap forward in improving prostate cancer early detection: a non-invasive and accurate imaging test for clinically significant prostate cancer.

The 2 groups in the trial

  • Early Detection Cohort (MRI with DBSI)Treatment being tested

    * Magnetic resonance imaging (MRI) with DBSI analysis prior to prostate biopsy * Standard of care prostate biopsy will be performed within 12 weeks of MRI * Some participants may go on to receive standard of care radical prostatectomy and those participants may have their prostatectomy specimens scanned via MRI with DBSI imaging

    Treatment: MRI with DBSI analysis

  • Active Surveillance Cohort (MRI with DBSI)Treatment being tested

    * Magnetic resonance imaging (MRI) with DBSI analysis prior to prostate biopsy * Standard of care prostate biopsy will be performed within 12 weeks of MRI * Some participants may go on to receive standard of care radical prostatectomy and those participants may have their prostatectomy specimens scanned via MRI with DBSI imaging

    Treatment: MRI with DBSI analysis

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Diffusion Basis Spectrum Imaging of the Prostate: A Virtual Biopsy to Accurately Diagnose Prostate Cancer
Plain-language title
Imaging test to detect prostate cancer without a biopsyGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
9 November 2026